Catheter apparatus for percutaneous coronary intervention capable of accurately positioning stent and balloon in a desired position

ABSTRACT

A catheter apparatus for percutaneous coronary intervention (PCI) capable of accurately positioning the balloon and stent in a desired position includes an introducer set fixed to an opening of the human artery, a guiding catheter secured to the introducer set and introduced into the artery, a Y-connector coupled with the guiding catheter, a guidewire introduced into the guiding catheter, a balloon catheter introduced into the guiding catheter and having a balloon at the distal end thereof, a minute adjustment portion having a nut and a bolt for minutely adjusting the insertion portion of the balloon catheter in the artery, a combining frame having two legs eachcoupled with the main tube and the nut, respectively, and a clamping portion for holding the balloon catheter firmly in position. The catheter apparatus provided by the present invention helps the physician to place the balloon and stent more accurately in the desired position of the artery so that the PCI operation becomes more accurate, easier and safer.

This application is a 371 ofPCT/KR2003/001321 filed on Jul. 4, 2003,published on Mar. 18, 2004 under publication number WO 2004/021930 A1which claims priority benefits from Korean patent application number KR10-2002-0054323 filed Sep. 9, 2002.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to an improved catheter apparatus forpercutaneous coronary intervention (PCI), and more particularly to acatheter apparatus for PCI whereby a balloon catheter can be moved moreaccurately to place a balloon formed at the distal end of the ballooncatheter and a stent mounted on the balloon in a position of a humancoronary artery having a cardiovascular disease such as a stenoticlesion.

2. Description of the Related Art

Coronary arteries of a human blood circulation system are tubes thatsupply the heart with oxygen, blood and nutritive substances. The leftand right coronary arteries branching off from the ascending aortaspread over the surface of the heart as if to enclose the heart.

PCI has recently become a commonly performed technique for treatingcardiovascular diseases such as stenotic lesions and abrupt vesselclosure of coronary arteries. A stenotic lesion is an abnormal narrowingof an artery usually due to atherosclerosis.

More than 15,000 PCI procedures are performed yearly in the Republic ofKorea, and it has been estimated that more than 100,000 procedures areperformed annually in Japan and more than 1,000,000 procedures areperformed annually in the U.S.

In PCI treatment, a balloon catheter is inserted through a femoral orbrachial artery of the patient to introduce the balloon formed at thedistal end of the balloon catheter to the obstructive lesion of thecoronary artery. Next, inflation of the balloon with a fluid (i.e.contrast media) causes the obstructive lesion of the coronary artery tobecome more open.

PCI treatment also involves the introduction into the coronary artery ofa stent, which generally has a metal tubular meshwork structure and ismounted on the inflatable balloon at the distal end of the ballooncatheter, through the femoral artery or the brachial artery, and theintroduction of the balloon and the stent to the stenotic lesion of thecoronary artery. Subsequently, the balloon is inflated with a fluidwhich expands the stent causing the stent to undergo a plasticdeformation, thereby installing the stent within the walls of thecoronary artery. After the balloon is deflated and pulled back out ofthe lesion, the stent is left behind in place so as to keep the blockageopen by continuously supporting the interior walls of the artery withradial force.

FIG. 1B is an illustration of the conventional catheter apparatus 1 forPCI including a balloon catheter, a guiding catheter, etc., in which allparts of the apparatus are assembled. FIG. 1C is an illustration of thecatheter apparatus 1 shown in FIG. 1B, in which certain pieces aredisassembled from the whole apparatus. FIG. 1D is an illustration of astent 8 mounted on the inflatable balloon 5 a at the distal end of theballoon catheter 5 shown in FIGS. 1B and 1C.

A conventional catheter apparatus 1 for PCI includes a Y-connector 2, anintroducer set 3, a guiding catheter 4, a balloon catheter 5, aguidewire 6, a clamp 7 and a stent 8. Among these components, theY-connector has a main tube 2 a and a side tube 2 b. The guidingcatheter 4 which is introduced into the introducer set 3 is coupled withthe main tube 2 a of the Y-connector 2. The guidewire 6 and the ballooncatheter 5 pass through the main tube 2 a of the Y-connector 2, and theside tube 2 b is coupled with a pipe of a manifold 9.

The manifold 9 has a plurality of pipes that are coupled with a pressuresensing device 9 a, a physiological saline solution bottle 9 c and acontrast media injection syringe 9 d, respectively. In addition, themanifold 9 has a plurality of valves for controlling the flows ofseveral fluids, installed inside the pipes of the manifold 9,respectively.

As much as is needed of the contrast media contained in the contrastmedia bottle 9 c may be injected into the patent's artery by way of thecontrast media injection syringe 9 d.

The balloon catheter 5 has a dual lumen structure in which a guidewirepassage lumen 5 f extends through a contrast media passage lumen 5 e. Aballoon 5 a is integrally formed at the distal end of the ballooncatheter 5 which is introduced into the artery. The balloon catheter 5has a balloon inflation port 5 d at its proximal end. The guidewirepassage lumen 5 f extends from the distal end of the balloon catheter 5to a guidewire passage opening 5 b at a predetermined position of theballoon catheter 5 where the guidewire exits from the balloon catheter5.

The balloon 5 a of the balloon catheter 5 is connected to the contrastmedia passage port 5 b through the contrast media passage lumen 5 e.Thus, the contrast media may be injected into or extracted from thecontrast media passage lumen 5 e by manipulating a balloon inflationsyringe 5 c so as to inflate or deflate the balloon 5 a.

Moreover, the guidewire 6 is inserted into the guidewire passage lumen 5f. The guidewire passage lumen 5 f formed inside the balloon catheter 5extends from the distal end of the balloon catheter 5 to reach theguidewire passage opening 5 b. It should be noted that the distal end ofthe guidewire passage lumen 5 f is adjacent to the balloon 5 a, and theproximal end of the guidewire passage lumen 5 f forms the guidewirepassage opening 5 b.

The guidewire 6 passes through the guidewire passage lumen 5 f so thatthe distal portion of the guidewire 6 closely passes by the balloon 5 a,and the proximal portion of the guidewire 6 passes through the guidewirepassage opening 5 b to exit from the balloon catheter 5.

As stated, the balloon catheter 5 of a dual lumen structure having theguidewire passage lumen 5 f extending through the contrast media passagelumen 5 e over almost the entire length of the balloon catheter 5 iscalled an “over-the-wire type balloon catheter”. On the contrary, aballoon catheter called a “monorail type balloon catheter” has analternative structure in which a guidewire passage lumen is formed onlyin the vicinity of the distal portion of the balloon catheter and theguidewire exits from the middle of the balloon catheter.

Procedures of PCI treatment will be explained hereinafter with referenceto the over-the-wire type balloon catheter. FIG. 1A is an illustrationof conventional PCI treatment, and FIGS. 2A through 2D are sequentialillustrations of PCI treatment.

(1) First, a portion of the femoral artery or the brachial artery of apatient is punctured with a needle to make an opening so that theintroducer set 3 can be installed at the opening of the artery.

Then, the guiding catheter 4 is pushed through the introducer set 3 soas to reach a place near an inlet of the coronary artery (FIG. 1A).

(2) The Y-connector 2 is coupled with the guiding catheter 4.Subsequently, the guidewire 6 may be introduced into the Y-connector 2so as to pass through the guiding catheter 4, thereby placing the distalend of the guidewire 6 in the coronary artery (FIGS. 1A and 1B).

(3) Next, the proximal end of the guidewire 6 is inserted into theguidewire passage lumen 5 f adjacent to the balloon 5 a of the ballooncatheter 5. By thrusting the guidewire 6 forward, the proximal end ofthe guidewire 6 travels through the guidewire passage lumen 5 f andexits from the guidewire passage opening 5 b. The balloon catheter 5 isintroduced into the artery by using the guidewire 6 as something like arailroad, so that the balloon catheter 5 can be easily slid through theartery.

(4) When the balloon 5 a of the balloon catheter 5 arrives at thecoronary artery, the contrast media is injected into the coronary arteryby way of the manifold 9. With the help of the contrast media, thephysician can identify the position of a stenotic lesion D (i.e. anarrow portion of the coronary artery) on an X-ray fluoroscope.

(5) By moving the balloon catheter backward or forward in the artery,the physician can place the balloon 5 a mounted at the distal end of theballoon catheter 5 and the stent 8 mounted on the balloon 5 a in theexact position of the stenotic lesion D (FIGS. 2A and 2B). When thecontrast media contained in the balloon inflation syringe 5 c isinjected into the balloon 5 a by way of the contrast media passage lumen5 e of the balloon catheter 5, the balloon 5 a inflates so as to expandthe stent 8 radially outward (FIG. 2C). The expanded stent holds up theartery walls that have been occluded due to the stenotic lesion D, so asto prevent recontraction of the walls. After the stent 8 is completelysecured to the artery walls, the balloon 5 a may be deflated bymanipulating the balloon inflation syringe 5 c conversely. Then, theballoon catheter 5 may be pulled out of the guiding catheter 4 to leavethe stent 8 behind in the coronary artery (FIG. 2D).

The conventional PCI treatment stated above requires that the physicianmust move the balloon catheter 5 very minutely on the guidewire 6,relying on the sense of his or her hands while watching the X-rayfluoroscope, in order to place the balloon 5 a in the exact position ofthe stenotic lesion D. However, it is very difficult for even aphysician having great manual skills at pushing forward or pullingbackward the balloon catheter in the artery, to adjust the balloonexactly to the position of the stenotic lesion in a short time. Thus, akey to the success of PCI treatment is that the stent should beinstalled exactly at the position of the stenotic lesion.

To position the balloon and stent exactly in the middle of the stenoticlesion of a coronary artery in PCI treatment, the physician has toinject the radioactive contrast dye multiple times into the coronaryartery while moving the balloon catheter manually. The accuratepositioning of the balloon and stent depends on the physician's handsand is not an easy task. The balloon and stent usually tend to move moreor less than desired. However, even if the physician pays much attentionto his or her manual movements, it is usually difficult to attainperfect positioning of the balloon and stent on a stenotic lesion of thecoronary artery.

In PCI treatment using the conventional catheter apparatus, since thephysician has to make small changes to the position of the ballooncatheter by depending on his or her manual dexterity, it is verydifficult to install the stent exactly at the position of the stenoticlesion (especially, at a curved or tortuous lesion) due to an excessivemovement of the balloon and stent in the arteries. This may result inthe installation of the stent in a less than optimal position, therebycausing less than ideal results. In addition, it takes much time toperform PCI treatment using the conventional catheter apparatus.Accordingly, the patient has to experience much pain due to the extendedtime of the operation, thereby adversely affecting the patient'sprognosis.

SUMMARY OF THE INVENTION

The present invention provides an improved catheter apparatus for PCIcapable of accurately positioning the balloon and stent at the site ofan obstructive coronary artery lesion in such a convenient way that theaccuracy of the PCI treatment can be enhanced and the operation time canbe reduced.

To accomplish the above object, a catheter apparatus for PCI accordingto the present invention includes an introducer set 130 introduced to anopening of the human artery; a guiding catheter 140 introduced throughthe introducer set 130 and into the artery so as to extend apredetermined distance into the artery; a Y-connector 110 having a maintube 111 and a side tube 112 which branches off from the main tube 111,the Y-connector being coupled with the guiding catheter 140; a guidewire160 introduced into the main tube 111 and the guiding catheter 140; aballoon catheter 150 introduced into the guiding catheter 140, having aballoon at the distal end thereof and a passage formed longitudinallythrough the balloon catheter 150, the passage providing a route for theguidewire 160; a minute adjustment portion 190 including a nut 192 and aminute adjustment bolt 191 engaging with the screw thread formed on theinner walls of the nut 192 and rotating so as to move backward orforward through the nut 192, the minute adjustment bolt 191 having athrough hole 191 b formed longitudinally thereinside so that the ballooncatheter 150 can pass through the through hole 191 b; a combining frame120 having two legs, one leg being coupled with the circumferentialsurface of the main tube 111 and the other leg being coupled with thecircumferential surface of the nut 192; and a clamping portion forholding the balloon catheter 150 passing through the minute adjustmentportion 190 firmly in position.

Also, an alternative catheter apparatus for PCI according to the presentinvention to accomplish the above object, comprises an introducer set130 introduced to an opening of the human artery; a guiding catheter 140introduced through the introducer set 130 and into the artery so as toextend a predetermined distance into the artery; a Y-connector 110having a main tube 111 and a side tube 112 which branches off from themain tube 111, the Y-connector being coupled with the guiding catheter140; a guidewire 160 introduced into the main tube 111 and the guidingcatheter 140; a balloon catheter 150 introduced into the guidingcatheter 140, having a balloon at the distal end thereof and a passageformed longitudinally through the balloon catheter 150, the passageproviding a route for the guidewire 160; a first bolt 195 coupled withthe main tube 111 and having a screw portion on its circumferentialsurface, the screw portion wound in a predetermined direction; a secondbolt 196 having a screw portion on its circumferential surface, thescrew portion wound in an opposite direction to the screw portion of thefirst bolt 195, the end portion of the second bolt 196 being coupledwith the end portion of the first bolt 195; a minute adjustment nut 193having two oppositely wound screw portions and being coupled with thefirst and second bolts 195 and 196, concurrently, one screw portionengaging with the first bolt 195 and wound in the same way as the screwthread of the first bolt 195, and the other screw portion engaging withthe second bolt 196 and wound in the same way as the screw thread of thesecond bolt 196; and a clamping portion for holding the balloon catheter150 passing through the minute adjustment nut 193 firmly in position.

BRIEF DESCRIPTION OF THE DRAWINGS

The above and other features and advantages of the present inventionwill become more apparent by describing in detail exemplary embodimentsthereof with reference to the attached drawings in which:

FIG. 1A is an illustration of the PCI treatment using the conventionalcatheter apparatus including a guidewire, a balloon catheter, etc.;

FIGS. 1B and 1C are illustrations of the conventional catheter apparatusfor PCI including the balloon catheter shown in FIG. 1A;

FIG. 1D shows the stent mounted on the balloon formed at the distal endof the balloon catheter, the stent being inserted into the coronaryartery by means of the balloon catheter;

FIGS. 2A through 2D are the sequential illustrations of PCI treatmentfor the stenotic lesion D occurring in the coronary artery CA of thepatient P, using the balloon catheter 5 and the stent 8;

FIG. 3 shows a catheter apparatus for PCI capable of accuratelypositioning stent and balloon in a desired position according to a firstembodiment of the present invention;

FIG. 4 is a side view of the catheter apparatus of FIG. 3, and FIG. 5 isa longitudinal cross-sectional view of the catheter apparatus of FIG. 3;

FIG. 6 shows a catheter apparatus for PCI capable of accuratelypositioning stent and balloon in a desired position according to asecond embodiment of the present invention;

FIG. 7 is an illustration of the catheter apparatus of FIG. 6, with theparts of the balloon catheter disassembled, and FIG. 8 is a perspectiveview of the catheter apparatus of FIG. 7, excluding the minuteadjustment nut 193 therefrom; and

FIG. 9A is a detailed view of the Y-connector 110 and the minuteadjustment nut 193 of the apparatus shown in FIG. 6, and FIG. 9B showsthe combination of a first bolt 195 and a second bolt 196.

BEST MODE FOR CARRYING OUT THE INVENTION

Hereinafter, the catheter apparatus for PCI capable of accuratelypositioning stent and balloon in a desired position according to thepresent invention will be described with reference to the attacheddrawings.

FIG. 3 shows a catheter apparatus for PCI according to a firstembodiment of the present invention. FIG. 4 is a side view of thecatheter apparatus of FIG. 3, and FIG. 5 is a longitudinalcross-sectional view of the catheter apparatus of FIG. 3.

Referring to FIGS. 3, 4 and 5, a Y-connector 110, an introducer set 130,a guiding catheter 140, a balloon catheter 150, a guidewire 160 and astent 180 are the same as those shown in FIGS. 1B and 1C. Therefore, adetailed description of those components will be omitted.

The catheter apparatus 100 for PCI according to the present inventionincludes a U-shaped combining frame 120 with clips 121 and 122 formed atthe respective ends thereof. The first clip 121 can be coupled with acircumferential surface of a main tube 111, and can be separated fromthe main tube 111 by pulling the first clip 121 from the circumferentialsurface of the main tube 111. Moreover, the second clip 122 formed atthe other end of the combining frame 120 can be coupled with acircumferential surface of a nut 192, and can be separated from the nut192 by pulling the second clip 122 from the circumferential surface ofthe nut 192.

A minute adjustment bolt 191 can be screwed back and forth through thenut 192. A minute adjustment portion 190 comprises the minute adjustmentbolt 191, the nut 192, and a bearing 194 which is installed inside arotating cylinder 191 a. The rotating cylinder 191 a is integrallyformed as part of the minute adjustment bolt 191.

Rotation of the rotating cylinder 191 a causes the minute adjustmentbolt 191 to be screwed backward or forward through the nut 192.

The balloon catheter 150 passes through a through hole 191 b of theminute adjustment bolt 191 and the main tube 111 of the Y-connector 110.Since the bearing 194 is installed inside the rotating cylinder 191 a,the balloon catheter 150 maintain its straightness without gettingtwisted when the rotating cylinder 191 a rotates. An inner wheel of thebearing 194 is integrated with a clamping bolt 170 which has a pluralityof forks 170 a. The outer surface of the forks 170 a is formed withthreads so that the forks 170 a can be tightened up by a clamping nut171.

The balloon catheter 150 passes through a through hole formed inside theclamping bolt 170 and extends in the direction of the longitudinal axisof the clamping bolt 170, and it further passes through a hole formed inthe center of the clamping nut 171, so that the balloon catheter 150 canbe fixed in place by tightening up the clamping nut 171.

As described above, the minute adjustment bolt 191, the bearing 194, therotating cylinder 191 a, the clamping bolt 170 and the clamping nut 171are combined to form a minute adjustment portion for adjusting theposition of the balloon catheter in an artery. Rotation of the rotatingcylinder 191 a causes the bearing 194, but not the clamping bolt 170 andclamping nut 171, to rotate. When the rotating cylinder 191 a isrotated, the clamping bolt 170 and the clamping nut 171 do not rotatebut move together with the minute adjustment bolt 191.

As shown, the balloon catheter 150 is prevented from moving with respectto the minute adjustment bolt 191 by means of the coupling of theclamping bolt 170 and the clamping nut 171, while not being twisted.Therefore, rotation of the rotating cylinder 191 a in a clockwise orcounterclockwise direction makes it possible to minutely move theballoon catheter 150 inward or outward with reference to the artery.

Since conventional catheter apparatuses for PCI are directly movedinward or outward through the artery by the physician's manual action,it is difficult for the physician to supply sufficiently small changesto the balloon catheter to exactly position the balloon catheter.

However, since the catheter apparatus 100 for PCI according to thepresent invention as stated above permits the balloon catheter 150 tomove as little as just one thread pitch along the screw thread formed onthe circumferential surface of the minute adjustment bolt 191 per onerotation of the minute adjustment bolt 191, the physician can moreaccurately and reliably manipulate the movement of the balloon catheterin an artery.

Reference numeral 150 b denotes a guidewire passage opening throughwhich the guidewire 160 passes so as to exit from the balloon catheter,and reference numeral 150 c denotes a balloon inflation syringecontaining the contrast media which can be injected into the ballooninflation port 150 d, and reference numeral 151 denotes the contrastmedia passage lumen that is connected to the balloon. After placing theballoon 150 a in the desired position of the coronary artery, thephysician presses the balloon expansion syringe 150 c so that thecontrast media passes through the contrast media passage lumen 151 toinflate the balloon 150 a. Inflation of the balloon 150 a causes thestent 180 to expand radially outward so that the stent dilates theoccluded, narrow portion of the coronary artery to enable the blood toflow more freely.

Reference numeral 150 d denotes a balloon inflation port through whichthe contrast media passes so as to inflate the balloon.

The guidewire 160 is introduced into a guidewire passage lumen 152partly adjoining the balloon 150 a at the distal end of the ballooncatheter 150, and exits from the balloon catheter 150 at a predeterminedposition along the balloon catheter 150 through the guidewire passageopening 150 b. Moreover, reference numeral 112 a denotes a manifoldconnection port with which the manifold 9 may be coupled as shown inFIGS. 1B and 1C.

FIG. 6 shows a catheter apparatus for PCI according to a secondembodiment of the present invention. FIG. 7 is an illustration of thecatheter apparatus of FIG. 6, with certain parts of the apparatusdisassembled, and FIG. 8 is a perspective view of the catheter apparatusof FIG. 7, excluding the minute adjustment nut 193. FIG. 9A is adetailed view of the Y-connector 110 and the minute adjustment nut 193of the apparatus shown in FIG. 6, and FIG. 9B shows the combination of afirst bolt 195 and a second bolt 196.

The catheter apparatus for PCI according to the second embodiment of thepresent invention differs from that of the first embodiment statedabove, in that the mechanism for minutely adjusting the insertionposition of the balloon catheter in the artery comprises a first bolt195, a second bolt 196 and a minute adjustment nut 193.

The first bolt 195 is integrated with the main tube 111 of theY-connector 110, and it has a first screw portion 195 a on itscircumferential surface. The second bolt 196 has a second screw portion196 a on its circumferential surface. The screw thread of the firstscrew portion 195 a is wound in the opposite direction to the screwthread of the second screw portion 196 a. That is, assuming the firstscrew portion 195 a has a left hand screw thread on its circumferentialsurface, the second screw portion 196 a has a right hand screw thread onits circumferential surface, or vice versa.

Referring to FIG. 9A, two screw portions are formed on the inner wallsof the through hole of the minute adjustment nut 193; the two screwportions correspond with the first and second screw portions 195 a and196 a, respectively, and one screw portion has its screw thread wound inthe opposite direction to the screw thread of the other screw portion.That is, the screw portion formed inside the minute adjustment nut 193and engaging with the first bolt 195 is wound in the same direction asthe first screw portion 195 a, and the screw portion formed inside theminute adjustment nut 193 and engaging with the second bolt 196 is woundin the same direction as the second screw portion 196 a.

Referring to FIG. 9B, the first bolt 195 has a receiving hole 195 bwhich extends along the central axis of the first bolt 195. The secondbolt 196 has a core 196 b extending from the end surface of the secondscrew portion 196 a. The core 196 b is inserted into the receiving hole195 b.

The receiving hole 195 b has a protruding key 195 c on the inner wallsthereof, and the core 196 b has a key groove 196 c formed on the surfacethereof. Thus, the protruding key 195 c of the receiving hole 195 bengages with the key groove 196 c of the core 196 b. Meanwhile, theclamping bolt 170 is integrated with the second bolt 196.

In accordance with the above described configuration, the first andsecond bolts 195 and 196 remained untwisted without rotating withrespect to each other during the rotation of the minute adjustment nut193, so that they move towards or apart from each other when the minuteadjustment nut 193 rotates in the direction of “A” or “B” as shown inFIGS. 6 and 7. That is, assuming that the first screw portion 195 aformed on circumferential surface of the first bolt 195 is a left handscrew and the second screw portion 196 a formed on the circumferentialsurface of the second bolt 196 is a right hand screw, rotation of theminute adjustment nut 193 in the direction of “A” causes the first andsecond bolts 195 and 196 to move apart from each other so that theballoon catheter 150 moves outward from the artery. On the contrary,rotation of the minute adjustment nut 193 in the direction of “B” causesthe first and second bolts 195 and 196 to move towards each other sothat the balloon catheter 150 moves toward the inside of the artery.

As for the catheter apparatus for PCI according to the second embodimentof the present invention, one rotation of the minute adjustment nut 193causes the balloon catheter 150 to move back or forth into an artery bytwo thread pitches of the screw thread of the minute adjustment nut 193.Thus, the physician can adjust the insertion position of the ballooncatheter 150 with greater accuracy by rotating the minute adjustment nut193 little by little so that the balloon 150 a secured to the distal endof the balloon catheter 150 can be placed in the exact position wherethe stenotic lesion occurs.

As for the catheter apparatus for PCI according to the second embodimentof the present invention, the first bolt 195 has the receiving hole 195b thereinside, and the second bolt 196 has a core 196 b. Moreover, thereceiving hole 195 b has the protruding key 195 c on its inner walls,and the core 196 b has the key groove 196 c on its circumferentialsurface.

However, it is also possible to make variations in the configuration ofthe of the first and second bolts 195 and 196 as stated above so thatthe first and second bolts do not rotate with respect to each other inspite of the rotation of the minute adjustment nut 193.

According to the catheter apparatus for PCI provided by the presentinvention, the physician can minutely and conveniently adjust theinsertion position of the balloon catheter by rotating a control handle(i.e. the rotating cylinder or minute adjustment nut) little by littlewhile watching the X-ray fluoroscope so that PCI treatment requiringhigh precision and accuracy in placing the balloon and stent in theexact position of stenotic lesion can be performed successfully,performed successfully, thereby reducing the operation time.

Furthermore, the mechanical configuration according to the presentinvention making it possible to minutely adjust the insertion positionof the balloon catheter can be easily adapted to any other catheterapparatus for introducing a catheter into the human internal organs suchas the peripheral arteries, the urethra, the bronchi, the gall tubes,etc., for medical analysis and/or treatment, thereby allowing theposition of the distal end of the catheter to be conveniently andminutely adjusted.

While the present invention has been particularly shown and describedwith reference to exemplary embodiments thereof, it will be understoodby those of ordinary skill in the art that various changes in form anddetails may be made therein without departing from the spirit and scopeof the present invention as defined by the following claims.

1. A catheter apparatus for percutaneous coronary intervention capableof accurately positioning stent and balloon in a desired position,comprising: an introducer set 130 introduced to an opening of the humanartery; a guiding catheter 140 introduced through the introducer set 130and into the artery so as to extend a predetermined distance into theartery; a Y-connector 110 having a main tube 111 and a side tube 112which branches off from the main tube 111, the Y-connector being coupledwith the guiding catheter 130; a guidewire 160 introduced into the maintube 111 and the guiding catheter 140; a balloon catheter 150 introducedinto the guiding catheter 140, having a balloon at the distal endthereof and a passage formed longitudinally through the ballooncatheter, the passage providing a route for the guidewire 160; a minuteadjustment portion 190 including a nut 192 and a bolt 191 engaging witha screw thread formed on the inner walls of the nut 192 and rotating soas to move backward or forward through the nut 192, the bolt 191 havinga through hole 191 b formed longitudinally thereinside so that theballoon catheter 150 passes through the through hole 191 b; a combiningframe 120 having two legs, one leg being coupled with thecircumferential surface of the main tube 111 and the other leg beingcoupled with the circumferential surface of the nut 192; and a clampingportion for holding the balloon catheter 150 passing through the minuteadjustment portion 190 firmly in position.
 2. The catheter apparatus asclaimed in claim 1, wherein the combining frame 120 includes a firstclip 121 coupled with the circumferential surface of the main tube 111and capable of being separated from the main tube 111, and a second clip122 coupled with the circumferential surface of the nut 192 and capableof being separated from the nut
 192. 3. The catheter apparatus asclaimed in claim 1, wherein the minute adjustment portion 190 furthercomprises a rotating cylinder 191 a integrally formed with the bolt 191.4. The catheter apparatus as claimed in claim 1, wherein the clampingportion includes a bearing 194 formed inside the bolt 191, a clampingbolt 170 fixed to the bearing 194, and a clamping nut 171 cooperatingwith the clamping bolt 170 to hold the balloon catheter 150 passingthrough the bearing 194 firmly in position.
 5. The catheter apparatus asclaimed in claim 3, wherein the clamping portion includes a bearing 194formed inside the bolt 191, a clamping bolt 170 fixed to the bearing194, and a clamping nut 171 cooperating with the clamping bolt 170 tohold the balloon catheter 150 passing through the bearing 194 firmly inposition.
 6. A catheter apparatus for percutaneous coronary interventioncapable of accurately positioning stent and balloon in a desiredposition, comprising: an introducer set 130 introduced to an opening ofthe human artery; a guiding catheter 140 introduced through theintroducer set 130 and into the artery so as to extend a predetermineddistance into the artery; a Y-connector 110 having a main tube 111 and aside tube 112 which branches off from the main tube 111, the Y-connectorbeing coupled with the guiding catheter 130; a guidewire 160 introducedinto the main tube 111 and the guiding catheter 140; a balloon catheter150 introduced into the guiding catheter 140, having a balloon at thedistal end thereof and a passage formed longitudinally through theballoon catheter, the passage providing a route for the guidewire 160; afirst bolt 195 fixedly coupled with the main tube 111 and having a screwportion on its circumferential surface, the screw portion wound in apredetermined direction; a second bolt 196 having a screw portion on itscircumferential surface, the screw portion of the second bolt wound inan opposite direction to the screw portion of the first bolt 195, an endportion of the second bolt 196 being coupled with an end portion of thefirst bolt 195; a minute adjustment nut 193 having two oppositely woundscrew portions and being concurrently coupled with the first and secondbolts 195 and 196, one screw portion engaging with the first bolt 195and wound in the same way as the screw thread of the first bolt 195, andthe other screw portion engaging with the second bolt 196 and wound inthe same way as the screw thread of the second bolt 196; and a clampingportion for holding the balloon catheter 150 passing through the minuteadjustment nut 193 firmly in position.
 7. The catheter apparatus asclaimed in claim 6, wherein the clamping portion includes a clampingbolt 170 fixed to the second bolt 196 and a clamping nut 171 cooperatingwith the clamping bolt 170 to hold the balloon catheter 150 firmly inposition.
 8. The catheter apparatus as claimed in claim 6, wherein thefirst bolt 195 has a receiving hole 195 b extending along the centralaxis of the first bolt 195 from the threaded end of the first bolt 195 apredetermined distance thereinto and having a protruding key 195 c onthe inner walls thereof, and the second bolt 196 has a core 196 bexending from the end surface of the screw portion of the second bolt196 and inserted into the receiving hole 195 b, the core 196 b having akey groove 196 c formed on the surface thereof to couple with theprotruding key 195 c.
 9. The catheter apparatus as claimed in claim 6,wherein the first bolt 195 has a receiving hole 195 b extending alongthe central axis of the first bolt 195 from the threaded end of thefirst bolt 195 a predetermined distance thereinto and having a keygroove formed on the inner walls thereof, and the second bolt 196 has acore 196 b exending from the end surface of the screw portion of thesecond bolt 196 and inserted into the receiving hole 195 b, the core 196b having a protruding key formed on the circumferential surface thereofto couple with the key groove.
 10. The catheter apparatus as claimed inclaim 6, wherein the first bolt 195 has a core exending along thecentral axis of the first bolt 195 and having a protruding key on thecircumferential surface thereof, and the second bolt 196 has a receivinghole having a key groove formed on the inner walls thereof, the keygroove being couple with the protruding key.
 11. The catheter apparatusas claimed in claim 6, wherein the first bolt 195 has a core exendingalong the central axis of the first bolt 195 and having a key grooveformed on the circumferential surface thereof, and the second bolt 196has a receiving hole having a protruding key on the inner walls thereof,and receiving the core, the protruding key being couple with the keygroove.